MDCG 2019-8 v2 – Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of…
Posts published in “Europe”
MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or…
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR)
COM(2020) 93 – Identifying and addressing barriers to the Single Market SWD(2020) 54 – Business Journey on the Single Market: Practical Obstacles and Barriers COM(2020)…
Team-NB-Position paper on Dental Implants-20200311-V1
So new draft agendas were published for some of the next MDCG meetings. Here are some topics that caught my attention (besides the important general…
MANUAL OF THE WORKING GROUP ON COSMETIC PRODUCTS (SUB- GROUP ON BORDERLINE PRODUCTS) ON THE SCOPE OF APPLICATION OF THE COSMETICS REGULATION (EC) NO 1223/2009…
Czech Notified Body Yet to Apply Under MDR as Others Prep for Post-May Designations